Intra-gastric fastening devices

ABSTRACT

Intra-gastric fastening devices are disclosed herein. Expandable devices that are inserted into the stomach of the patient are maintained within by anchoring or otherwise fixing the expandable devices to the stomach walls. Such expandable devices, like inflatable balloons, have tethering regions for attachment to the one or more fasteners which can be configured to extend at least partially through one or several folds of the patient&#39;s stomach wall. The fasteners are thus affixed to the stomach walls by deploying the fasteners and manipulating the tissue walls entirely from the inside of the organ. Such fasteners can be formed in a variety of configurations, e.g., helical, elongate, ring, clamp, and they can be configured to be non-piercing. Alternatively, sutures can be used to wrap around or through a tissue fold for tethering the expandable devices. Non-piercing biased clamps can also be used to tether the device within the stomach.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 10/215,070,filed Aug. 7, 2002, which is incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

The present invention relates generally to medical apparatus andmethods. More particularly, the present invention relates to devices andmethods for the attachment of expandable devices and the like within apatient's body cavity, such as the stomach, intestine orgastrointestinal tract.

BACKGROUND OF THE INVENTION

In cases of severe obesity, patients may undergo several types ofsurgery either to tie off or staple portions of the large or smallintestine or stomach, and/or to bypass portions of the same to reducethe amount of food desired by the patient, and the amount absorbed bythe intestinal tract. Procedures such as laparoscopic banding, where adevice is used to “tie off” or constrict a portion of the stomach, orthe placement of intragastric balloons can also achieve these results.

Endoscopic procedures that have been used to assist weight loss havebeen primarily focused on the placement of a balloon or otherspace-occupying device in the patient's stomach to fill portions of thestomach to provide the patient with the feeling of fullness, therebyreducing food intake. To accomplish these procedures, an endoscope isutilized to guide the balloon through the patient's mouth and down theesophagus to the stomach. Usually these procedures have allowedplacement of the device for 6-12 months, and are coupled with counselingand other types of psychological support.

Many of the conventional surgical interventions require the patient tosubmit to an intervention under general anesthesia, and can requirelarge incisions and lengthy recovery time. The less invasive procedures,although clinically efficacious in many cases, suffer from complicationsranging from deflation of the devices to insufficient anchoring of thesedevices resulting in unsustained weight loss, stomach erosion, bowelobstruction and even death.

Many of these devices are neither robust enough nor are they adequatelysecured within the stomach to sustain long term implantation. As aresult, many implanted devices are implanted in such a manner as toremain unattached or free-floating within the stomach. Further, due tothe caustic nature of stomach acids and other factors, many of theimplants deflate and migrate into the intestine, causing bowelobstructions and in some cases death. Also, many devices are not welldesigned for removal, leading to additional technical difficulties forthe clinician.

BRIEF SUMMARY OF THE INVENTION

The present invention provides for the improved methods and apparatusfor implanting and anchoring space-occupying devices into thegastrointestinal system of a patient, e.g., the stomach of the patient,that can be deployed in a minimally invasive manner such astransesophageal endoscopy. The invention allows greater access toprocedures and devices by patients who might not otherwise be treatedsurgically as “morbidly obese” (at or above a Body Mass Index (BMI) of40 kg/m3), but who may just be moderately obese or overweight (BMI ofbetween 25 to 40 kg/m3). In addition, patients who require more invasivesurgery for an unrelated ailment, may need a minimally invasive way tolose the weight prior to their more invasive procedure, thereby reducingthe risks associated with general anesthesia, or otherwise enabling themore invasive procedure.

Expandable devices that may be inserted into the stomach of a patientmay be maintained within the stomach by anchoring or otherwise fixingthe device to the stomach wall of the patient. Such expandable devices,e.g., an inflatable balloon, may comprise two portions, an inner portionand an outer portion, the inner portion being able to maintain itsshape, regardless of the integrity of the outer portion. Otherexpandable balloon devices which may be used may maintain their expandedshape and desired volume, independent of any small leaks that maydevelop over time or they may be configured to maintain a volume of thespace-occupying device which can be adjusted in-situ, to change the sizeof the device after implantation.

The space-occupying devices preferably have a tethering region forattachment to one or more fasteners. The fasteners are configured suchthat portions of the fasteners may extend at least partially through oneor several folds of the patient's stomach wall, thereby maintaining thedevice within the patient's stomach, but do not extend external to thepatient's body. The fasteners may thus be affixed to the stomach wallsby deploying the fasteners and manipulating the tissue walls entirelyfrom the inside of the organ.

Such fasteners may be formed in a variety of configurations, e.g.,helical, elongate, ring, clamp, and they may optionally be configured tobe non-piercing. For example, sutures may simply be used to wrap aroundor through a tissue fold for tethering the space-occupying devices.Alternatively, non-piercing biased clamps may also be used to tether thedevice within the stomach.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a schematic illustration of a delivery endoscope advancedto a region of interest within the stomach of a patient.

FIG. 2A shows a cross-sectional view of a stomach within which a tissuefold has been formed from the walls of the stomach.

FIG. 2B shows the stomach of FIG. 2A in which an inflatable orspace-occupying member (in its deflated or unexpanded state) has beenadvanced for anchoring to the tissue fold.

FIG. 3 shows the stomach of FIGS. 2A and 2B in which the space-occupyingmember has been expanded for deployment.

FIG. 4A shows a variation of a helically-shaped fastener which has beenpositioned within the tissue fold for anchoring the space-occupyingmember.

FIGS. 4B and 4C show side and end views, respectively, of the fastenerof FIG. 4A.

FIG. 5A shows another variation of an elongate fastener which has beenpositioned within multiple tissue folds.

FIG. 5B shows a side view of the fastener of FIG. 5A.

FIG. 6 shows another variation of a ring-shaped fastener which has beenpositioned within the tissue fold.

FIG. 7A shows an end view of another variation of a clamp fastener.

FIG. 7B shows a side view of the clamp fastener of FIG. 7A.

FIG. 8 shows another variation in which a piercing or non-piercingsuture is used as a fastener for anchoring the space-occupying member tothe tissue.

FIG. 9A shows yet another variation of a clamp fastener.

FIGS. 9B and 9C show cross-sectional side and end views, respectively,of the clamp fastener of FIG. 9A.

DETAILED DESCRIPTION OF THE INVENTION

Expandable devices that may be inserted into the stomach of a patientmay be maintained within the stomach by anchoring the device to thewalls of the stomach using intra-gastric fasteners. Although thefastening devices described herein describe anchoring within a stomach,this is merely illustrative and the fasteners may be utilized in anyhollow body organ or interior body space for temporarily or permanentlyanchoring expandable devices to tissue. FIG. 1 illustrates a deliveryendoscope 10 which may be used to deliver the expandable devices as wellas the fastening devices into, e.g., stomach 18 of a patient. Endoscope10 is shown as having been advanced through the mouth 12 and esophagus14 of the patient to position the distal end of endoscope 10 within aregion of interest 20 within stomach 16.

FIG. 2A shows a cross-sectional view of stomach 16 within whichendoscope 10 has been positioned adjacent to region of interest 20. Atleast one tissue fold 50 is formed from within the lumen of stomach 16utilizing any number of conventional tools which may be passed throughthe working channel of endoscope 10, or any of the tissue acquisitiondevices as described in further detail in U.S. patent application Ser.No. 09/871,297 filed May 30, 2001 or U.S. patent application Ser. No.10/188,547 filed Jul. 2, 2002, both of which are commonly owned and areincorporated herein by reference in their entirety.

The tissue layers of stomach 16 are comprised of the mucosal layer 32,the muscularis or fibrous muscular layer 34, and the serosal layer 36.In preferably forming tissue fold 50, at least two layers of stomachtissue are folded to contact itself such that a certain amount offibrous tissue overlap occurs prior to fastening tissue fold 50 in aconfiguration akin to a lap joint. The amount of the overlap can varyand needs only to be sufficient enough to result in joining of thefastened sections, thereby creating a tissue bridge along the length ofthe fastened tissue. The tissue bridge may be formed of various layersof the stomach and may include scar tissue and other elements ofeffective wound healing. Once tissue fold 50 has been desirablyconfigured, a fastener or anchor (as described in further detail below)may be used to maintain the tissue fold configuration for anchoring aspace-occupying device thereto.

Once tissue fold 50 has been formed, the space occupying device, e.g.,an expandable scaffold, an inflatable balloon, etc., may be advancedwithin stomach 16 towards the region of interest 20 for anchoring totissue fold 50. As shown in FIG. 2B, space-occupying member 30 may beadvanced using an elongate delivery member 21, e.g., endoscope 10 or anyone of the delivery devices as shown and described in U.S. patentapplication Ser. No. 09/816,850 filed Mar. 23, 2001, which is commonlyowned and is incorporated herein by reference in its entirety. The useof an inflatable balloon in these examples is intended to beillustrative and any number of space-occupying devices, such as anexpandable scaffold, may be utilized as described in the incorporatedapplication. Space-occupying member 30 may have a tethering region 22integrated on its distal end in the shape of, e.g., a tethering ring orclasp, for attachment to the fastener or anchor which maintains tissuefold 50. During delivery, space-occupying member 30 may be advancedtransorally in its deflated state using delivery member 21. Deliverymember 21 may also be used to deliver an inert inflation fluid, e.g.,water, saline, etc., or an inert gas, e.g., nitrogen, air, etc., througha lumen defined within member 21 for expanding space-occupying member 30during deployment.

As seen in FIG. 3, delivery member 21 may be used to inflatespace-occupying member 30 into its expanded shape 30′. The surface ofspace-occupying member 30′ may have one or several tabs 40 extendingfrom or defined along its outer surface to allow a grasping tool tomanipulate or remove space-occupying member 30′ during the procedure orpost-procedurally. Space-occupying member 30 may be affixed to tissuefold 50 by attaching tethering region 22 to the fastener or anchor whichmaintains tissue fold 50. The attachment may be accomplished prior to,during, or even after inflation or expansion of member 30 and may bedone by any number of manipulation tools endoscopically orlaparoscopically delivered and positioned, as appreciated by one skilledin the art.

Space-occupying member 30 may be formed of a urethane interior and asilicone exterior. The urethane provides a durability to the balloon forresisting undesirable rupture or leakage and the silicone exteriorprovides for a smoothness, and conformability to avoid unnecessarytrauma or irritation to the stomach lining. In another variation, themember 30 is formed of a composite of silicone, aluminized polyesterfilm, and polyethylene. In this variation, the space occupying device isformed by heat-sealing sheets of mylar/polyethylene composite. The seamis then trimmed to a minimum size and a valve attached. The assembly isthen dipped in room temperature vulcanizing (RTV) liquid silicone which,once cured, will leave a smooth surface, which may or may not have apalpable seam. Alternatively, the space occupying device can be rotatedas the silicone cures, to allow for a more consistent coating to form.

A variety of sizes and shapes of space-occupying member 30 arecontemplated, and it is to be appreciated that one skilled in the artwould be competent to choose a particular shape and size according tothe particular application. The space-occupying member 30 can be, forexample, a spherical or ellipsoidal balloon or another suitable shape.In the case of an ellipsoidal balloon, one method of anchoring such aballoon is along the longer axis of the balloon; however, anchoring mayalso be achieved by anchoring along the shorter axis of the balloon.Balloon volumes can vary, but a typical volume is approximately 500cubic centimeters (cc).

FIGS. 4A to 4C show various views of one variation of an anchoringdevice which may be utilized to maintain the configuration of tissuefold 50 as well as to affix space-occupying member 30 to tissue fold 50.FIG. 4A shows a side view of a helically-shaped fastener 52 piercedthrough tissue fold 50. Variation 52 is a fastener having a plurality,i.e., more than one, of helical coils 56, as shown in the side view offastener 52 in FIG. 4B. Fastener 52 preferably has a distal tip 54 whichis sharpened to facilitate piercing into and advancement through tissuefold 50 while being rotatingly advanced. FIG. 4C shows an end view inwhich fastener 52 is preferably formed into a circular configuration toprovide for smooth advancement and rotation into the tissue, althoughother shapes such as elliptical are contemplated. It is to fastener 52that tethering region 22 may be affixed directly or by using abiocompatible connecting member, e.g., a suture.

Fastener 52 is shown as having helical coils 56 at a uniform pitch.However, fastener 52 may be modified such that the pitch of helicalcoils 56 is non-uniform. In such a variation, the location along coils56 where the tissue is ultimately compressed may have a pitch which istighter or higher than the rest of fastener 52. The tighter pitch allowsfor increased tissue compression along that portion of fastener 52. Theremaining helical coils 56 may have a lower or looser pitch tofacilitate insertion into the tissue.

Fastener variation 52, as well as other fastening devices describedherein, are preferably made of metallic or non-metallic biocompatiblematerials. Such materials may include stainless steels, nickel alloys,and titanium alloys, as well biocompatible plastics. Moreover, any ofthe fasteners may additionally be coated with a healing agent oranti-bacterial agent to facilitate tissue growth and healing.

Additionally, the fasteners may have a cutting, abrading, scoring,heating, freezing, chemically damaging, or some other damaging surfacewhere it contacts the tissue. This scoring or roughening may damage theinterior lining of the tissue contacting each other. This damage mayencourage a more vigorous healing response and a more permanent fixationbetween the damaged tissue once stapled or affixed together. Detailedexamples may be found in U.S. patent application Ser. No. 09/871,297filed May 30, 2001, which is commonly owned and is incorporated hereinby reference in its entirety.

FIGS. 5A and 5B show another variation of an anchoring device. In thisvariation, another tissue fold 50′ in addition and adjacent to tissuefold 50 may be utilized. Although two tissue folds are shown, any numberof folds may be used as practicable depending upon the desired resultsand anchoring configuration. Fastener variation 60 may include astraight member having rounded ends 62 to facilitate the anchoringplacement and positioning within tissue folds 50, 50′. As shown in FIG.5B, the length of fastener 60 may be textured 64 to improve tissuehealing as well as to prevent excessive fastener movement oncepositioned within the tissue. Space-occupying member 30 may be attachedto fastener 60 using tether or connecting member 66, which may be asuture or a rigid connecting pin.

Another tissue-piercing fastener variation is shown in FIG. 6, whichshows a ring-shaped fastener 70 which may pierce tissue fold 50 andconnect to tethering region 22 of space-occupying member 30. Ring 70 maybe formed as a C-clip type fastener which is biased to remain a closedloop but which may be urged open during deployment. A partial length orthe full length of ring 70 surface may be textured, as described above.Moreover, a single ring 70 or several rings may be deployed within thetissue to anchor to the same space-occupying member 30 or to multiplemembers 30, depending upon the desired results and configuration.

Yet another variation of the fastener is shown in FIGS. 7A and 7B. FIG.7A shows an end view of clamp fastener 80 which is comprised of twoopposed clamp members which are preferably biased towards one anotherabout a hinge portion 82. Fastener 80 may be made of a spring stainlesssteel or a shape memory alloy, e.g., nickel-titanium alloy, and may bepre-configured into its clamp configuration. As shown in FIGS. 7A and7B, edges 84 may have beads attached around the entire periphery of theclamp or partially thereon either by an adhesive or by forming the beadsintegrally with the clamp 80. Alternatively, edges 84 may be bluntedduring manufacturing to provide atraumatic edges for presentation to thetissue surface.

Clamp 80 may be formed in a variety of shapes, e.g., in a binder clipconfiguration, a “taco” shell configuration, etc., or any other shapewhich provides contact surfaces 86 having a contact area sufficient toenable secure anchoring to the tissue. Contact surfaces 86 may be formedwith additional anchoring devices such as barbs 88, surface texturing,and/or felt or another tissue in-growth-promoting material. If barbs 88are used, any number may be used in a variety of barb configurations,e.g., angled barbs, etc.

To affix space-occupying member 30 to fastener 80, a rotating joint 90may be used. In this variation, clamp 80 may have attached connector 96having a balled pivot 94 at a distal end. Tethering region 22 ofspace-occupying member 30 may have a receiving ring for rotatinglyreceiving pivot 94. Joint 90 may be utilized on any of the fastenersdescribed herein and allows space-occupying member 30 to rotate freelyabout the joint without regards to the orientation of clamp 80. This mayaid in minimizing tissue tears and excess stress applied to tissue fold50 as space-occupying member 30 is moved about. To deploy clamp 80, itmay be urged into an “open” configuration as it is advanced over tissuefold 50 by the delivery device. Once in position over the tissue, clamp80 may then be released allowing it to compress upon the tissue tobecome affixed to tissue fold 50.

Another fastener variation 100 is shown in FIG. 8. Suture 100 may simplybe used to wrap around tissue fold 50. In this variation, suture 100 maybe optionally pierced through the tissue or it may simply be wrapped anumber of times around tissue fold 50 to affix space-occupying member30. Suture 100 may be made of any suitable material, e.g., stainlesssteel, nylon, polypropylene, or any other conventional suturingmaterial.

Yet another variation is shown in FIGS. 9A to 9C of a non-piercing clampfastener 110. Fastener 110 in this variation is comprised of at leasttwo opposed collar portions 112 which are connected by a biasingconnecting member 114. Member 114 is preferably configured to provide abiasing force such that portions 112 are urged towards one another.Collar portions 112 collectively define a receiving channel 116 throughwhich tissue fold 50 may be positioned and held. Contact walls 118 ofreceiving channel 116 may be smooth and non-piercing, but they mayoptionally have a number of teeth or barbs which project into channel116 for completely or partially penetrating the tissue held therewithin.Moreover, contact walls 118 may have its area varied depending upon theshape and area of the tissue surface presented. For instance, if thetissue area for attachment is formed in the shape of a uvula, then thearea of contact walls 118 may be minimized and optionally tapered toreceive the bulging contact tissue. If the tissue area is formed more asa fold of tissue, the area of contact walls 118 may be enlarged topresent a larger contact region to the tissue, as in the variation ofFIGS. 7A and 7B.

With the collar portions 112 clamping onto tissue fold 50, suitablegrasping or holding pressure is applied by the fasteners to maintainattachment to tissue fold 50. If too much pressure is applied, thetissue 50 being compressed may necrose, but if too little pressure isapplied, slippage of fastener 110 may occur. Accordingly, the suitableamount of pressure may be determined by one of skill in the artdepending upon factors such as the size of tissue fold 50 and the sizeof fastener 110, among other factors.

Although preferred illustrative variations of the present invention aredescribed above, it will be evident to one skilled in the art thatvarious changes and modifications may be made without departing from theinvention. For instance, variations of the present invention may be usedas permanent or temporary anchoring devices. Moreover, modifiedvariations may also be used in other regions of the body, e.g., for usein the intestinal tract, etc. It is intended in the following claims tocover all such changes and modifications that fall within the truespirit and scope of the invention.

We claim:
 1. A method of anchoring an object to a region of tissuewithin a hollow body organ, comprising: grasping the region of tissuefrom an interior surface of the hollow body organ; configuring theregion of tissue to create at least one fold of tissue; and securing afastener to the fold of tissue such that the object fixedly depends fromthe fastener and is affixed to the fold of tissue within the hollow bodyorgan.
 2. The method of claim 1 further comprising advancing anendoscope transorally to the region of tissue.
 3. The method of claim 1wherein the hollow body organ comprises a stomach.
 4. The method ofclaim 1 wherein grasping the region of tissue comprises holding thetissue with a vacuum force.
 5. The method of claim 1 wherein graspingthe region of tissue comprises holding the tissue mechanically.
 6. Themethod of claim 1 wherein the anchor is helically-shaped.
 7. The methodof claim 1 wherein the anchor comprises at least one rounded end tofacilitate placement within the tissue.
 8. The method of claim 1 whereinthe anchor is biased to form a curved member within the tissue.
 9. Themethod of claim 1 wherein the anchor comprises at least one protrusionadapted to extend within the tissue.
 10. A system for occupying a volumewithin a lumen of a hollow body organ, comprising: a space-occupyingmember; and an anchor adapted to be secured to at least one fold oftissue created from an interior surface of the hollow body organ,wherein the space-occupying member is secured to the anchor which isaffixed to the fold of tissue within the hollow body organ.
 11. Thesystem of claim 10 wherein the anchor comprises a helically-shapedfastener.
 12. The system of claim 10 wherein the anchor comprises amember having at least one rounded end.
 13. The system of claim 10wherein the anchor comprises a biased ring.
 14. The system of claim 10wherein the anchor is adapted to at least partially pierce into the foldof tissue.
 15. The system of claim 10 wherein the anchor comprises asuture.
 16. The system of claim 10 wherein the anchor comprises a clamp.17. The system of claim 10 wherein the anchor is at least partiallycoated with a biocompatible agent.